Medical Device Approval Manufacturers, Suppliers & Companies
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Manufacturerbased in Mason, OHIO (USA)
AtriCure is a medical device company that provides innovative solutions designed to decrease the global Afib epidemic. As a leading provider of innovative technologies for the treatment of Atrial Fibrillation (Afib) and related conditions, ...
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Manufacturerbased in Sterling, MASSACHUSETTS (USA)
BMP Medical is your preferred source for custom OEM injection molded medical devices. We are a privately held company that has been in business for over 40 years. We use state of the art molding techniques and machinery to produce varying sized ...
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Manufacturerbased in Widnau, SWITZERLAND
Microlife is a world market leader in the development and production of medical diagnostic equipment - for use at home and in health facilities. Microlife is the world’s leading manufacturer of thermometers. The company is also one of the world ...
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Technologybased in Basel, SWITZERLAND
Aurealis Therapeutics, a Swiss-Finnish private biopharmaceutical company, is now entering the clinical trial phase with its patented three-in-one combination product AUP-16 for chronic non-healing wounds and other regenerative diseases. The ...
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Manufacturerbased in Warriewood, AUSTRALIA
From the Australian Outback to the Middle East, Asia, Europe, Antarctica, and North America, Visionflex technology provides access to high quality healthcare anywhere, anytime. Established by two Australian engineers, Visionflex has been a ...
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Manufacturerbased in Langhorne, PENNSYLVANIA (USA)
Syncro Medical takes quality very seriously. We’re software craftsmen – attention to quality is part of our culture and embedded in every aspect of how we deliver our services. Competition within the medical device industry continues to intensify. ...
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Manufacturerbased in Feldkirch, AUSTRIA
A.M.I. – Agency for Medical Innovations – is an Austrian manufacturer of medical technology based near the shores of Lake Constance, within easy reach of both Germany and Switzerland. From here we develop, manufacture and distribute our medical ...
A.M.I. - Comfort Drain for Anal Fistulas
The Comfort Drain from is the first means of long-term drainige for treatment of inter-, trans-, and supra-sphincteric fistulas designed for knot-free closure, thus offering patients the maximum possible comfort. The first medical ...
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Manufacturerbased in Lake VIlla, ILLINOIS (USA)
SAI was founded in 1995 with the goal of helping researchers develop and implement reliable infusion techniques. We want infusion and sampling to be low-stress for both the researcher and the subject. Throughout our 20+ years, we have become known ...
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Manufacturerbased in Didcot, UNITED KINGDOM
We design, develop and manufacture nanofibrous biomaterials for medical devices and regenerative medicine. Our technology platform is built on electrospinning and associated processing technologies. We are supporting clients with material ...
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Manufacturerbased in Hangzhou, CHINA
Chemical Inspection and Regulation Service (CIRS) is a leading product safety and chemical management consulting firm providing valued product regulatory compliance service, tailored solutions and original information to help our clients gain ...
Medical Device Regulation Compliance Services
Medical Devices and In Vitro Diagnostics Product Regulatory Compliance in China. Pre-market Investigation & Analysis. Medical Devices Registration & ...
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Manufacturerbased in Jinan, CHINA
Founded in 2003, Jinan Babio Biotechnology Co., Ltd. is a professional high-tech enterprise which concentrates on the R&D, manufacturing and selling of in vitro diagnostic reagent. The company was successfully listed on the NEEQ (National Equities ...
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Service providerbased in Dortmund, GERMANY
KombiMED GmbH has been operating in the German market since 2017, catering to customers in Eastern Europe and the Commonwealth of Independent States (CIS). Our clientele includes clinical diagnostics and food laboratories, medical facilities, ...
KombiMEd - Medical Device Product Registration Services
Approval of medical devices in the Commonwealth of Independent States. Since the approval of medical devices in the Commonwealth of Independent ...
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Manufacturerbased in Planegg, GERMANY
REGUMED is a medical technology company operating internationally with cooperation partners and therapists in over 90 countries. For more than 30 years we have been committed to improving the quality of people´s lives. In order to achieve this we ...
BICOM optima - Model mobil - Bioresonance Device
The BICOM bioresonance device is available in two versions. Doctors and naturopathic practitioners can choose between the BICOM optima and the BICOM optima mobil. Both versions are approved as a certified ...
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Manufacturerbased in Miami Lakes, FLORIDA (USA)
DemeTECH Corporation is a world-renowned leader in surgical sutures, mesh and bone wax. DemeTECH strives to enhance doctor-patient relationships through hard work, dedication, and a commitment to the pursuance of cutting-edge technology and ...
Regulatory Services
DemeTech’ s regulatory team can do all validations needed for your product. Also, our full regulatory team can help obtain FDA, CE and ISO approval for your medical device. ...
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Manufacturerbased in Monmouth Junction, NEW JERSEY (USA)
CytoSorbents Corporation is a leader in critical care immunotherapy, specializing in blood purification. Its flagship product, CytoSorb® is approved in the European Union with distribution in 58 countries around the world, as an extracorporeal ...
CytoSorb - Adsorber
The CytoSorb adsorber is a CE-marked Class IIb medical device that is specifically approved for the removal of cytokines, bilirubin and myoglobin. Next to this CytoSorb is indicated for use ...
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Software vendorbased in Heidelberg, GERMANY
Molecular Health is an international biotech IT company based in Heidelberg, Germany, that has been developing innovative software in the areas of in silico and precision medicine since 2004. Molecular Health’s solutions make it possible to ...
Molecular Health - Dataome Technology
Reliable predictions to anticipate risks. Interlinked data to find new targets and design novel drugs. Real-world evidence to evaluate success. These capabilities eliminate the uncertainties that limit drug development but are data-intensive and ...
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Manufacturerbased in Gangwon-do,, SOUTH KOREA
IBEX MEDICAL SYSTEMS CO.,Ltd. is the leader of a medical technology development using the oxygen. Utilizing the medical technology for respiration, we will improve the quality of life for many patients, medical service providers, and general public ...
IBEX MiraDry - Non-invasive Medical Device
Sweat-reducing effects in clinical test results / US FDA Approved / Non-invasive Medical ...
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Manufacturerbased in Seongdong-gu, SOUTH KOREA
Daeju Meditech Engineering Co., Ltd. is a medical equipments manufacturer which invested in order to penetrate the medical equipments market has been providing since the inception of the business in 1996. Daeju Meditech Engineering Co., Ltd. is a ...
Daeju - Model HIPRO-V - High Intensity Focused Ultrasonic System
With only one Hand Piece without the additional cartridges. HIPRO-V delivers HIFU energy to SMAS layer which is located between subcutaneous tissues and muscle, or deep dermsi, or the fat layers in body. And then, makes 0.7 ~ 1.0 mm size of ...
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Manufacturerbased in Malmö, SWEDEN
At Flow Neuroscience we develop a new kind of depression treatment which combines an easy-to-use brain stimulation headset with an engaging, personalized mobile app to target both the physical and behavioural elements of major depressive disorder ...
Flow - Headset Delivers Transcranial Direct Current Stimulation (tDCS) Device
The Flow tDCS headset delivers transcranial Direct Current Stimulation (tDCS) in a small and portable device. By combining intuitive design that requires minimal setup and training, short sessions that match the length of most TV ...
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Manufacturerbased in Miami, FLORIDA (USA)
We are the regenerative medicine company that develops and delivers innovative allograft solutions designed to support the body’s healing and regenerative potential to help improve patient outcomes and quality of life. VIVEX Biologics processes, ...
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